A Phase 2, Parallel-Group, Double-Blind, Placebo-Controlled Study to Investigate Weight Management With LY3841136 and Tirzepatide, Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes

Status: Recruiting
Location: See all (51) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to investigate the safety and efficacy of LY3841136 for chronic weight management alone or in combination with Tirzepatide across a wide dose range in participants with Type 2 Diabetes. Participation in the study will last about 64 weeks.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

⁃ W8M-MC-LAA2

• Have a Body Mass Index (BMI) of ≥27 kilograms per square meter (kg/m²)

• Have Type 2 Diabetes

• Have a HbA1c ≥7.0 % (53 millimoles/mole (mmol/mol)) to ≤10.5% (91 mmol/mol) and treated with diet and exercise alone or with a stable dose of metformin (and not more than the locally approved dose) with or without a sodium-glucose cotransporter 2 (SGLT2) inhibitor for at least 3 months prior to screening

⁃ W8M-MC-CWMM:

• Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss)

Locations
United States
Arizona
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
RECRUITING
Chandler
HOPE Research Institute
RECRUITING
Phoenix
Headlands Research - Scottsdale
RECRUITING
Scottsdale
The Institute for Liver Health II dba Arizona Liver Health-Tucson
RECRUITING
Tucson
California
NorCal Medical Research, Inc
RECRUITING
Greenbrae
Velocity Clinical Research, Huntington Park
RECRUITING
Huntington Park
Peninsula Research Associates
RECRUITING
Rolling Hills Estates
Diablo Clinical Research, Inc.
RECRUITING
Walnut Creek
Connecticut
Stamford Therapeutics Consortium
RECRUITING
Stamford
Florida
Northeast Research Institute (NERI)
RECRUITING
Fleming Island
Indago Research & Health Center, Inc
RECRUITING
Hialeah
New Horizon Research Center
RECRUITING
Miami
Suncoast Clinical Research, Inc.
RECRUITING
New Port Richey
Charter Research - Winter Park
RECRUITING
Orlando
Charter Research - Lady Lake
RECRUITING
The Villages
Iowa
Iowa Diabetes and Endocrinology Research Center
RECRUITING
West Des Moines
Idaho
Medical Research Partners
RECRUITING
Ammon
Illinois
Great Lakes Clinical Trials - Andersonville
RECRUITING
Chicago
Great Lakes Clinical Trials - Ravenswood
RECRUITING
Chicago
NorthShore University Health System
RECRUITING
Skokie
Kansas
Cotton O'Neil Diabetes & Endocrinology
RECRUITING
Topeka
Massachusetts
Knownwell
RECRUITING
Needham
Lucida Clinical Trials
RECRUITING
New Bedford
Michigan
Headlands Research - Detroit
RECRUITING
Southfield
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
RECRUITING
Troy
Missouri
StudyMetrix Research
RECRUITING
Saint Peters
Clinvest Headlands Llc
RECRUITING
Springfield
North Carolina
Medication Management
RECRUITING
Greensboro
Monroe Biomedical Research
RECRUITING
Monroe
Lucas Research, Inc
RECRUITING
Morehead City
Lucas Research, Inc.
RECRUITING
New Bern
Nevada
Las Vegas Medical Research
RECRUITING
Las Vegas
New York
Dent Neurologic Institute
RECRUITING
Amherst
Velocity Clinical Research, Syracuse
RECRUITING
East Syracuse
North Suffolk Neurology
RECRUITING
Port Jefferson Station
Rochester Clinical Research, LLC
RECRUITING
Rochester
Ohio
CTI Clinical Research Center
RECRUITING
Cincinnati
South Carolina
Tribe Clinical Research, LLC
RECRUITING
Greenville
Tennessee
Quality Medical Research
RECRUITING
Nashville
Texas
IMA Clinical Research Austin
RECRUITING
Austin
FutureSearch Trials of Dallas
RECRUITING
Dallas
Velocity Clinical Research, Dallas
RECRUITING
Dallas
PlanIt Research, PLLC
RECRUITING
Houston
Endeavor Clinical Trials
RECRUITING
San Antonio
Tekton Research - Fredericksburg Road
RECRUITING
San Antonio
Texas Valley Clinical Research
RECRUITING
Weslaco
Virginia
Spectrum Medical, Inc.
RECRUITING
Danville
Washington
Central Washington Health Services Association d/b/a Confluence Health
RECRUITING
Wenatchee
Other Locations
Argentina
Centro Médico Viamonte
NOT_YET_RECRUITING
Buenos Aires
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
NOT_YET_RECRUITING
Ciudad Autonoma De Buenos Aires
Centro de Investigaciones Metabólicas (CINME)
NOT_YET_RECRUITING
Ciudad Autónoma De Buenos Aires
Contact Information
Primary
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
clinical_inquiry_hub@lilly.com
1-317-615-4559
Time Frame
Start Date: 2024-09-20
Estimated Completion Date: 2026-08
Participants
Target number of participants: 350
Treatments
Experimental: LY3841136 Dose 1
Participants will receive LY3841136 subcutaneously (SC)
Experimental: LY3841136 Dose 2
Participants will receive LY3841136 SC
Experimental: LY3841136 Dose 3
Participants will receive LY3841136 SC
Experimental: LY3841136 Dose 1 + Tirzepatide Dose 1
Participants will receive LY3841136 SC and Tirzepatide SC
Experimental: LY3841136 Dose 2 + Tirzepatide Dose 1
Participants will receive LY3841136 SC and Tirzepatide SC
Experimental: LY3841136 Dose 2 + Tirzepatide Dose 2
Participants will receive LY3841136 SC and Tirzepatide SC
Experimental: LY3841136 Dose 3 + Tirzepatide Dose 3
Participants will receive LY3841136 SC and Tirzepatide SC
Active_comparator: Tirzepatide Dose 3
Participants will receive Tirzepatide SC
Experimental: LY3841136 Dose 2 + Tirzepatide Dose 3
Participants will receive LY3841136 SC and Tirzepatide SC
Placebo_comparator: Placebo
Participants will receive placebo administered SC.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov